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- 2026-04-16 01:49:55
- Policy
- Budget Subcommittee passes KRW 965 bln for COVID-19 vaccine
- by Lee, Jeong-Hwan Nov 12, 2020 06:19am
- The Budget and Accounting Evaluation Subcommittee of the National Assembly Health and Welfare Committee has deliberated and decided on the 2021 budget plans for the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS) and the Korea Disease Control and Prevention Agency (KDCA). The subcommittee explained the infectious disease control and healthcare budget has been vastly expanded around 965 billion won for seeking COVID-19 vaccine, whereas unnecessary budget was cut boldly. Apparently, the infectious disease control and prevention budget of 965 billion won was newly allocated to get an access to COVID-19 vaccine. Moreover, 9.52 billion won was allocated to establish regional infectious disease specializing hospitals, and 88.14 billion won was increased for the budget to cover the influenza vaccine cost for the National Immunization Program (NIP) and to expand free immunization program for population aged 14 to 18 and 62 to 64. As for the healthcare sector, improving publicness of regional center hospital added the budget of 110.3 billion won. The subcommittee also put 18.8 billion won on top of the budget for mental health management and suicide prevention due to COVID-19 related depression and for creating a culture of respective human lives. Also the committee increased the government financial aid funding up to 209.2 billion won to lessen the National Health Insurance (NHI) premium in vulnerable community directly impacted by COVID-19. As for food and drug safety management, the budget of 1.77 billion won was additionally reflected to eradicate illegal online distribution of food and drugs, while 6.43 billion won was reflected to expand and enhance Children’s Meal Service Management Center to support small-scale kitchen for children’s meal service. The clinical trial safety standard reinforcing project and clinical trial management system to promote development of new drug including COVID-19 treatment received the budget of 5.32 billion won. Meanwhile, the Budget Evaluation Subcommittee significantly revised the KDCA budget, as an independent agency budget, because it was initially submitted to the National Assembly as a part of MOHW. The original budget plan under the MOHW approval allocated 36.10 billion won in 33 tax revenue programs and 341.86 billion won in 65 tax expenditure programs. But the plan was revisited and amended for the independent government institute of KDCA. Basically, the subcommittee provided a solid financial foundation for KDCA to execute infectious disease control and prevention as a standalone central administration agency. The Health and Welfare Committee is to convene a general meeting and to deliberate the budget plans passed by the subcommittee at 5 PM on the same day. The Budget and Accounting Evaluation Special Committee would then comprehensively assess the budget plans. The budget review procedure would be completed after the National Assembly plenary session passes the finalized plan.
- Policy
- Pfizer’s COVID-19 vaccine needs to be reviewed
- by Kim, Jung-Ju Nov 12, 2020 06:19am
- With the interim results announced that the effectiveness of the COVID-19 vaccine being developed together by Pfizer in the United States and BioNTech in Germany is more than 90% effective, the Korean government has decided to take a cautious approach in the future. It is because the clinical results of other products are expected to be released sooner or later, and safety is the top priority, so there is no need to worry about supply and demand. Joon-Wook Kwon, the second vice president of the Central Disease Control Headquarters (Director of the Korea National Institute of Health), answered the news of Phase III clinical trials of Pfizer's vaccine and the direction of response to supply and demand of vaccines in Korea through a briefing during the day on the 10th. Currently, Korea is in the process of securing the COVID-19 vaccine through bilateral consultations with some global pharmaceutical companies following the COVAX organization. However, the progress of pre-purchase is not disclosed through agreements with companies, but pre-purchase of products that have entered phase III clinical trials worldwide are being discussed. In other words, this drug also belongs to the group of drug candidates that Korea can select through international organizations that have already paid the advance payment. Pfizer's Phase III clinical trial is the fastest news among them. Pfizer analyzed 94 people infected with COVID-19 among the participants of Phase III on the 9th of the local time, and found that the drug being developed is showing a 90% preventive effect. However, in the case of Pfizer, the UK has already announced the pre-purchase, and Germany has also declared priority to supply its own people. Accordingly, the domestic supply and demand situation is also a concern. He said, "It is obvious that (Pfizer's phase III clinical trial) is in a good situation, so that it is difficult to find a case that achieved good results through clinical phase III in 9 months." also he added that we are looking at additional results and comprehensively reviewing various drugs being developed by other companies besides Pfizer. He said, “Based on our experience now, there are no cases of good results through phase III clinical trials in 9 months,” he said. “ However, as a quarantine authority, Pfizer confirmed additional results and Besides, we are looking at various drugs being developed by other companies.” However, we reaffirmed our cautious position on concern that the opportunity for Korea to pre-purchase will be diminished due to the supply of domestic companies by developers. He said, "It's not that we're going to do the pre-purchase slowly. The pre-purchase will do our best to proceed normally, but the actual vaccination results of other countries, and adverse reactions or problems occurring in the field, etc. "I will check closely and do it slowly." He also emphasized that "the vaccine will be carefully judged by watching the vaccination situation in other countries."
- Policy
- The re-evaluation of α-GPC will be implemented next month
- by Lee, Tak-Sun Nov 11, 2020 08:48am
- The MFDS stated that the clinical re-evaluation schedule of the brain function improving drug, Choline alfoscerate has not changed. The clinical plan must be submitted by the 23rd of next month. If the deadline is not met, the sale will be suspended immediately. Shin Seung-seung, an official of the Drug Safety Assessment Division of the MFDS, met with a reporter on the 10th and said this. She explained, "The companies must submit a reasonable plan to recruit enough subjects, it is about 90 days until the plan is reviewed, and it may be extended if supplementation comes out." In principle, the MFDS is in the position that all indications for Choline alfoscerate should undergo clinical reevaluation. However, if there is a basis in the plan submitted by the company, it will be carefully reviewed through expert advice. The industry argues that Choline alfoscerate should be excluded from clinical re-evaluation as it has been recognized for its clinical usefulness when re-evaluating the benefits of the HIRA in relation to the efficacy of dementia. Regarding this, she said, "there has not yet been received by companies or expert groups regarding clinical reevaluation." In addition, she said, "In order to maintain the indication, it is a principle to undergo clinical trials for the three approved effects, but a plan must be submitted first." Currently, the issue of reimbursement recovery on the premise of a clinical reevaluation failure is also being discussed. In this audit of the state administration, Nam In-soon, a member of Democratic Party of Korea, mentioned the necessity of a plan for insurance finances, and the MOHW also said, "We will review various measures including contracts between the NHIS and pharmaceutical companies. Accordingly, if the clinical reevaluation fails, the possibility of benefit redemption and negotiations with the related government and pharmaceutical companies increased. However, regardless of this, the MFDS plans to proceed with clinical re-evaluation without any change in schedule. She said, "We will share the data with the MOHW, but the clinical re-evaluation will proceed separately from the drug price issue, and the schedule will not be delayed." The deadline for submitting the clinical re-evaluation plan for Choline alfoscerate preparations is until December 23, and if this is the first violation, the product will be suspended for two months, the second will be suspended for 6 months, and the third will be canceled.
- Company
- GA leads newly appointed at KRPIA and global companies
- by Eo, Yun-Ho Nov 11, 2020 06:10am
- Multinational pharmaceutical companies in South Korea are busy processing a wave of new recruit changes, specifically happening around government affairs jobs. The pharmaceutical industry sources reported many of pharmaceutical companies, as well as Korean Research-based Pharmaceutical Industry Association (KRPIA), have announced a series of personnel news related to their Government Affairs (GA) and Market Access (MA) divisions. On Nov. 5, KRPIA welcomed Senior Manager Kim Minyoung as a successor to Senior Director Sean Kim to oversee MA and healthcare policy relevant tasks. Previously in charge of new drug listing at Amgen Asia Pacific, Senior Manager Kim has rich experience in marketing, GA and MA. Janssen Korea, on the other hand, appointed Senior Manager Kim Yeonhee to lead the MA team as of October, as the former MA Director Lim Kyunghwa was promoted to Janssen Asia-Pacific. Senior Manager Kim joined Janssen in 2000 as sales, and managed marketing and sales in Janssen China and Asia Pacific Region Office. Now she would also cover MA tasks as well. The anticancer drug part at MSD Korea recruited former Executive Director Park Dongjoon at Novartis as a new Senior Director in GA. Formerly affiliated under Daily Pharm as a reporter, Senior Director Park was in charge of government policy at Novartis since 2011. MSD seems to be expanding the anticancer drug business around an immunotherapy Keytruda to consolidate as a more independent sector. On the contrary, Novartis is currently in search of Park’s successor. Former MA Lead Kim Bo Kyung at UCB has apparently moved on to LG Chem as a MA Leader. UCB has not decided who would fill up Kim’s former position. Former MA Executive Director at Eisai Korea, Kim Kyongsun joined IQVIA as a part of Regulatory Affair (RA) division. Accordingly, Eisai is also looking for a new MA lead. A multinational company GA division insider commented, “As the division is an exceptionally specialized area, most of the specialists are highly sought after to take over the job immediately. So the industry frequently experiences a series of recruitment at once. But for GA in particular, some companies reach out to the National Assembly or news media outlet for the job offer.”
- Company
- A study on Korean patients by Nebilet are released
- by Nov 11, 2020 06:08am
- Menarini Korea (CEO Park Hye-young) presented the results of a BENEFIT subgroup study of Nebilet(Nebivolol, β-blocker) at the 53rd Fall International Conference on the Korean Society of Hypertension (Hypertension Seoul 2020). It was revealed on the 9th. The conference, which was held for two days from the 6th to the 7th, was conducted in the form of online streaming to prevent the spread of COVID-19 At this meeting, Seung-ju Cha, a doctor at Hanyang University Hospital, annonunced 'Impact of baseline pulse rate on the efficacy of Nebivolol in a real world clinical study for hypertension patients ', and Jaewon Lee at Hanyang University Hospital, said ‘Efficacy and safety of 2.5mg dose of Nebivolol in hypertension patients in a real world studies in Korea.’ In addition, Professor Sang Ki Cho of Kwangju Christian Hospital served as the chairman, and Professor Hak-Ryung Kim of SNU Boramae Medical Center introduced ‘Approaches to HTN Treatment with β-blockers : Findings from Real World Evidence.’ In addition, Professor Jong-young Lee of Kangbuk Samsung Hospital published the abstract of 'Efficacy and Safety of Nebivolol in the management of hypertension associated with coronary artery disease: BENEFIT-KOREA Research Results', who participated as the first author. Nebivolol is a third-generation β-blocker of hypertension treatment that selectively blocks β-1 receptors, which are mainly distributed in the heart. The advantage is that it produces Nitric oxide to dilate blood vessels, and that there is little risk of side effects of bronchospasm caused by β-2 blockade. Due to its high cardiac selectivity, it is advantageous for patients with high blood pressure with angina pectoris, myocardial infarction, tachyarrhythmia, or fast pulse. Menarini Korea conducted a BENEFIT study in 66 hospitals in Korea from July 2015 to March 2017 in which Nebilet was administered to 3250 adult hypertensive patients to observe the treatment effect for 24 weeks. The research results released on this day are the presentation of analysis results for subgroups as part of the BENEFIT study. Park Hye-young, CEO of Menarini Korea explained, "Nebilet, a third-generation β-blocker, is a product that minimizes side effects such as bradycardia, bronchospasm, and the effects of blood sugar and lipids, which were pointed out as disadvantages of the first-generation β-blockers, and enhances the blood pressure lowering effect." In addition, she said, "We will continue to prove the efficacy and safety of Nebilet through various studies to provide useful treatment options for Korean hypertensive patients."
- Product
- Pfizer’s all the items expected to be out of stock?
- by Jung, Heung-Jun Nov 11, 2020 06:08am
- Text messages received by pharmacists from wholesalersWhen some local wholesalers sent a text message to the pharmacy saying that all Pfizer items from Pfizer Korea are expected to be sold out, pharmacists are placing large orders to secure stock. The text message the pharmacy received from a wholesaler said that Pfizer stopped placing orders after sales of Pfizer this year, and accordingly, it is expected to sell out after the current inventory runs out. The pharmacists were reluctantly increasing the amount of orders, fearing the possibility of being sold out. However, Pfizer Korea announced that orders for sales will not be stopped this year. According to local pharmacies on the 8th, some received information about all Pfizer products, and others received information about some of the products scheduled to be sold out. The places that received the information on all products ordered a unit of ₩10 million and prepared for it in advance. Contrary to expectations, there are items that are not sold out, but they have to secure inventory to be used this year for fear of a possible out of stock. Drugs ordered to secure inventory after receiving a text message for all items sold out Pharmacist A in Gyeonggi-do said, "Last year, there was no notice that all items were expected to be sold out, and I received a text message saying that some products will be sold out." “This time I ordered about ₩14 million. This is the minimum quantity and ordered. I don’t care about other product, but Xanax is already out of stock.” Pharmacist A said, "In addition to these, there are products that are out of stock, and among them there are products that are almost out of stock." In addition, the pharmacist explained the situation in which he had no choice but to secure supplies in case of sold out. Some pharmacists were notified that only certain products of the company were sold out. Some products are scheduled to be sold out by December and others are scheduled to be sold out. As a result, some pharmacists were concerned about whether they were trying to sell all the remaining stock. Pharmacist B in Gyeonggi-do, said, "There are pharmacies that have received two items, not all items. They are talking about whether they are too explicit in inventory. Pfizer replied that the contents of this text message were not guided at all. An official from Pfizer explained, "The company has never provided guidance to wholesalers (such as text content), and does not take measures to stop placing orders just because sales are over." On the other hand, there was an opinion that if a wholesaler guided these texts, pharmacists would have no choice but to purchase in large quantities, and that fundamental supply and demand instability problems need to be resolved. Pharmacist C in Seoul, said, "It's not just about a specific company. There are dozens of out-of-stock drugs that pharmacies are having trouble with, and it's like a threat." He emphasized, "It is a recurring problem, so it is necessary to prevent prescriptions for sold-out drugs or to come up with a fundamental solution."
- Policy
- Yuhan’s no-food-required fenofibrate tablet approved
- by Lee, Tak-Sun Nov 11, 2020 06:07am
- Yuhan Corporation Yuhan Corporation has received the health authority’s approval on a fenofibrate tablet, orally taken regardless of meal consumption, to treat hyperlipidemia. The form and administration method are unique to the drug only in South Korea. GC Pharma with the original fenofibrate Lipidil supra is also in process of developing a tablet with the same dosage form. On Nov. 5, the Ministry of Food and Drug Safety (MFDS) granted an approval on Yuhan’s ‘Yuhan Fenofibrate 145 mg Tablet.’ Used to treat patients with primary hyperlipidemia, the newly approved drug in a 145-mg tablet is taken orally for once daily with or without having a meal. The existing fenofibrate tablets were in 160 mg dose and taken after a meal to facilitate the drug absorption. Yuhan conducted a bioequivalence test on its tablet drug and confirmed the equivalence with Abbott’s Tricor that has not been released in South Korea. Tricor is a new form of fenofibrate, approved by the U.S. Food and Drug Administration (FDA) in 2004. Unlike other fenofibrate forms, the absorption in gastrointestinal tract is faster and it can be consumed without food consumption. The unique form has not been introduced to the Korean market, yet. GC Pharma initially got ‘Lipidil NT’ approved for the market with the same substances and form, but the company dropped the license voluntarily in 2014. GC Pharma is currently working on developing the form. In last August, the company had a Phase 1 trial approved to compare its 145-mg fenofibrate tablet against Tricor as a reference drug. But Yuhan nabbed the item approval first and claimed the chance to open the market before GC Pharma. Besides fenofibrate, similar drugs like fenofibric acid and choline fenofibrate have a variety of products that can be taken without a prior food consumption. Hanmi Pharmaceutical’s Fenocid Capsule (fenofibric acid), Daewon Pharmaceutical’s TG Fenon Tablet (choline fenofibrate) and Korea Pharma’s Fenocholine Capsult (choline fenofibrate) are the examples. Abbott has also launched a combination drug Cholib Tablet (fenofibrate plus simvastatin). Although Abbott’s single agent drug Trilipix Capsule (choline fenofibrate) was approved for the market in 2013, the license was dropped when it was expired in January 2018. Recently, fenofibrate drugs have been used frequently to treat patients with hypertriglyceridemia. As one of hyperlipidemia, hypertriglyceridemia has a high prevalence rate and requires drug treatment to lower the cardiovascular event risk as it cannot be managed only through strict diet and exercise. Statin drugs are used the most on hyperlipidemia, but it demonstrate low response rate in drug administration. To cover the flaw, fenofibrate drugs are also prescribed usually in combination.
- Policy
- A tough market for new Rosuzet generic
- by Lee, Tak-Sun Nov 10, 2020 06:06am
- Hanmi Pharmaceutical’s rosuvastatin-ezetimibe combination drug Rosuzet Although the door for generics is to open next year when the post marketing surveillance (PMS) period is terminated for the rosuvastatin and ezetimibe combination drug treating dyslipidemia, the market annually generating 150 billion won is actually not expecting any new generic. Many of pharmaceutical companies have already received the South Korean health authority by manufacturing drugs on consignments with substituting evidence submission. Only the companies turn the consigned manufacturing to direct manufacturing are conducting bioequivalence test with the reference drug Rosuzet by Hanmi Pharmaceutical after the PMS termination. The Ministry of Food and Drug Safety (MFDS) reported on Nov. 9 that the ministry has granted approval for bioequivalence test on only four pharmaceutical companies to confirm body absorption of their drugs compared against Rosuzet. The approved companies are Aprogen Pharmaceuticals, HK inno.N, Korea Prime Pharm and Jeil Pharmaceutical. Aprogen Pharmaceuticals and Korea Prime Pharm did not have approved item by the point of bioequivalence test approval. But the two companies had their products approved recently through their consigned manufacturer by sharing the test result instead of running a direct test. Jeil Pharmaceutical and HK inno.N had already-approved items to receive the bioequivalence test approval. The already-approved products are manufactured on consignments. The bioequivalence test would be conducted to switch to direct manufacturing. Compared to the consigned manufacturing, directly manufacturing the products could raise the profit ratio. It also has an advantage of maintaining the drug pricing by meeting the condition of bioequivalence test result for the pricing reevaluation. HK inno.N is planning to improve the profit ratio of its Rovazet ranked at the third place in the market by conducting a bioequivalence test. Although there are only seven companies in South Korea manufacturing a rosuvastatin plus ezetimibe combination drug, there are 150 approved items by 50 companies. The seven companies include Hanmi Pharmaceutical with the first-listed Rosuzet, Yuhan with Rosuvamibe ranked at the second place, and other companies like Daewon Pharmaceutical, Shin Poong Pharm, Aju Pharm, Alvogen Korea, and Ildong Pharmaceutical. Among those companies, Daewon Pharmaceutical and Shin Poong Pharm are entrusted with manufacturing of the drug by four companies, Aju Pharm by 14 companies and Alvogen Korea by 20 companies. These drugs are technically not a generic. But they are incrementally modified drugs approved with evidence submission. The consigned items have also submitted the identical evidence for approval based on the shared material. Accordingly, the same PMS terms would be applied until June 7. Regardless of the market generating 150 billion won annually, a new generic drug is unlikely to be developed as companies that initially prepared for bioequivalence test rather shared the substituting evidence with other companies and received item approval. The already-listed drug’s pricing is set with a sum of 53.55 percent of each individual drug. So a new generic would not get reduced pricing. However, based on the stepped pricing system, a new generic could receive the lowest pricing when listed later. With 20 same substance drugs already listed since last June, a new applicant drug would be automatically priced at 85 percent of the lower price between the lowest price or 38.69 percent of the upper limit price. Hence, the worst environment for a new generic has been created. The pharmaceutical industry insider commented, “As for the rosuvastatin and ezetimibe combination drug market, too many companies have resorted to sharing the submitted evidence to avoid the stepped pricing. Most of the companies could actually enter the market before the PMS period ends.”
- Policy
- NA “Age over 65 pneumococcal vaccine should use Prevenar13"
- by Lee, Jeong-Hwan Nov 10, 2020 06:05am
- The National Assembly pointed out the National Immunization Program (NIP) for the pneumococcal vaccine for elderly population aged over 65 should be switched from the existing 23-valent pneumococcal protein polysaccharide vaccine (PPSV23) to 13-valent pneumococcal conjugate vaccine (PCV13). The lawmakers claim the state should provide expensive PCV13, instead of comparatively more inexpensive and less preventive PPSV23, to have proper preventive effect against pneumonia in high-risk population amid COVID-19 pandemic. As Prevenar 13 is the only approved PCV13 in South Korea, the National Assembly recommended the NIP to replace Pneumo 23 and Prodiax-23, currently provided for free of charge at public healthcare center, with Prevenar 13. On Nov. 4, the Senior Expert Committee Office of the National Assembly Budget and Accounting Evaluation Special Committee addressed the recommendation when reporting the review result of 2021 budget plan by Korea Disease Control and Prevention Agency (KDCA). The KDCA’s NIP budget plan for 2021 allocated 347.79 billion won with 9.04 billion won (2.7 percent) increased from this year. The NIP offers PPSV23 once as a pneumococcal vaccine for the elderly population aged over 65 at a public healthcare center. Due to COVID-19 hindering the immunization at the healthcare centers, the vaccine is provided temporarily from last June 22 to Dec. 31 this year at designated healthcare institute. The Expert Committee Office of the Budget and Accounting Evaluation Special Committee ordered KDCA to consider using PCV13 for the pneumococcal vaccination program to improve prophylaxis against pneumonia amid COVID-19 pandemic. At the moment, Pfizer Pharmaceutical Korea’s Prevenar 13 is the only PCV13 approved for the South Korean market. SK Bioscience was the first Korean company to develop and receive the health authority approval on a PCV13 Skypneumo, but the company lost a patent challenge against Prevenar 13 and had to voluntarily drop the license in South Korea as it failed to evade the patent. The committees explained the recommendation was made, because the number of deaths by pneumonia in elderly population aged over 65 has been increasing steadily in last five years and preventing pneumonia in high-risk group became crucial due to COVID-19. In fact, the number of deaths by pneumonia in population aged over 65 has been surging from 13,701, 15,263, 18,202, 21,820 to 21,855 in year 2015 through last year, respectively. The Expert Committee Office said, “The high-risk group with senior citizens and people with underlying disease forms less antibody with PPSV23 and their duration of sustained antibody is also short. So the vaccine’s preventive effect against pneumonia has been controversial. The 2018 guideline for adult immunization recommends combination of PCV13 and PCV13 in immunosuppressed, asplenic, cerebrospinal fluid leaking and cochlear implanted adults over age of 65 years, who have not been immunized with the vaccine before.” The office added, “While the COVID-19 pandemic has not been fully contained, the government should review providing PCV13 for the high-risk population of age over 65 years as a part of NIP to see effective prophylaxis against pneumonia.”
- Company
- Daewoong,enters phase III of indications for Enavogliflozin
- by Nov 10, 2020 06:05am
- Daewoong (CEO Seung-ho Jeon) announced on the 30th of last month that it had received approval for a phase III clinical trial from the MFDS for the combination therapy of Enavogliflozin, Metformin, and DPP-4 inhibitor, which are being developed as a new drug for diabetes treatment. Enavogliflozin is a new drug for the treatment of SGLT-2 diabetes being developed by Daewoong for the first time among Korean companies. In this phase III, the hypoglycemic effect and safety of the three-drug therapy will be confirmed in 250 patients with type II diabetes who do not sufficiently control blood sugar even if Metformin and a DPP-4 inhibitor are administered together. Clinical trials are conducted in about 20 large hospitals nationwide, including the Catholic University of Bucheon St. Mary's Hospital. As Daewoong is approved for this clinical trial, from Enavogliflozin's monotherapy and combination therapy with Metformin, to three-drug therapy, Enavogliflozin will be used as a treatment for patients whose blood sugar is not controlled even when co-administered with existing diabetes treatments. Daewoong plans to expand its market share by adding indications for Enavogliflozin. In particular, Enavogliflozin was designated as Korea's first rapid review target (Fast Track) drug, allowing the period of new drug approval to be shortened. Daewoong is aiming to be released in Korea in 2023. Seung-Ho Jeon, president of Daewoong said, "Daewoong is making further efforts to expand the indication for Enavogliflozin to help control blood sugar in type II diabetes patients from mild to moderate. Enavogliflozin is also planning to expand its treatment benefits by expanding various indications besides diabetes, as it is expanding into therapeutics.” Enavogliflozin is an SGLT-2 inhibitor that selectively inhibits the SGLT-2 transporter involved in the reabsorption of glucose in the kidneys and directly excretes glucose into the urine. As a result of the phase II study, when compared with placebo alone after 12 weeks of administration in type II diabetic patients, the change in glycated hemoglobin (HbA1c), a major indicator of blood sugar control, decreased by about 0.9% compared to placebo. This is the result of a reduction of more than about 30% compared to the existing SGLT-2 inhibitors that were conducted in Westerners. In addition, the global standard diabetes control target, 'the proportion of patients who reached below 7.0% of glycated hemoglobin' reached a maximum of 61%, and the proportion of patients whose glycated hemoglobin decreased by more than 0.5% compared to before treatment reached a maximum of 72%. As a result, it showed superior blood sugar reduction effect compared to the existing SGLT-2 inhibitor.
